Antibodies which specifically recognize inactive PSA, and uses thereof
OwnerJean-Philippe Charrier, Colette M Jolivet-Reynaud +1inventors
InventorsJean-Philippe Charrier, Colette M Jolivet-Reynaud, Sandrine Michel
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Abstract
The invention concerns antibodies capable of identifying the prostrate specific antigen (PSA) in non-complexed and inactive form, and their uses in methods for diagnosing an adenocarcinoma or benign prostatic hyperplasia.
Claims21
An antibody or antibody fragment which binds specifically to inactive free PSA, said antibody being a purified polyclonal antibody or a monoclonal antibody.
A method for diagnosing a benign pathology of the prostate or for differentiating between a benign pathology of the prostate and an adenocarcinoma of the prostate in an individual, in which the inactive free PSA content in a sample originating from said individual is measured.
A method for diagnosing an adenocarcinoma of the prostate in an individual suspected of suffering from said adenocarcinoma, in which:
- the amount of active free PSA and/or the amount of inactive free PSA in a sample taken from this individual is determined,
- where appropriate, the amount of a form of PSA other than active free PSA and other than inactive free PSA, in a sample of the same nature taken from the same individual, is determined,
- the value of one of the following ratios is determined:
- ratio of the amount of inactive free PSA to the amount of active free PSA,
- ratio of the amount of inactive free PSA to the amount of total free PSA,
- ratio of the amount of inactive free PSA to the amount of total PSA,
- ratio of the amount of inactive free PSA to the amount of complexed PSA,
- ratio of the amount of active free PSA to the amount of total free PSA,
- ratio of the amount of active free PSA to the amount of total PSA,
- ratio of the amount of active free PSA to the amount of completed PSA,
- or the inverses of these ratios, or combinations of these ratios,
- the value of the ratio thus determined is compared with a predetermined threshold value chosen, depending on the type of ratio used, such that the values of said ratio higher or, respectively, lower, than said threshold value are representative of the values observed in patients suffering from a recognized adenocarcinoma of the prostate, and such that, conversely, the values of said ratio lower or, respectively, higher, than said threshold value are representative of the values observed in individuals recognized not to be suffering from an adenocarcinoma of the prostate, and it is concluded, from the result of said comparison, either that an adenocarcinoma of the prostate is present, or that one is not present.
A diagnostic method which makes it possible to differentiate between a benign pathology of the prostate and an adenocarcinoma of the prostate in an individual suspected of suffering from one of these diseases, in which;
- the amount of active free PSA and/or the amount of inactive free PSA in a sample taken from this individual is determined,
- where appropriate, the amount of a form of PSA other than active free PSA and other than inactive free PSA, in a sample of the same nature taken from the same individual, is determined,
- the value of one of the following ratios is determined:
- ratio of the amount of inactive free PSA to the amount of active free PSA,
- ratio of the amount of inactive free PSA to the amount of total free PSA,
- ratio of the amount of inactive free PSA to the amount of total PSA,
- ratio of the amount of inactive free PSA to the amount of complexed PSA,
- ratio of the amount of active free PSA to the amount of total free PSA,
- ratio of the amount of active free PSA to the amount of total PSA,
- ratio of the amount of active free PSA to the amount of complexed PSA,
- or the inverses of these ratios, or combinations of these ratios,
- the value of the ratio thus determined is compared with a predetermined differentiation value chosen, depending on the type of ratio used, such that the values of said ratio which are higher or, respectively, lower, than said differentiation value are representative of the values observed in patients suffering from a recognized benign pathology of the prostate, and such that, conversely, the values of said ratio which are lower or, respectively, higher, than said differentiation value are representative of the values observed in individuals recognized as suffering from a recognized adenocarcinoma of the prostate, and it is concluded, from the result of said comparison, either that there is a benign pathology of the prostate or that there is an adenocarcinoma of the prostate.
A diagnostic kit for diagnosing an adenocarcinoma of the prostate in an individual suspected of suffering from said adenocarcinoma, or for differentiating between a benign pathology of the prostate and an adenocarcinoma of the prostate in an individual suspected of suffering from one of these diseases, said kit comprising:
- means for assaying inactive free PSA in a biological sample, and/or
- means for assaying active free PSA in a biological sample of the same nature and, optionally,
- means for assaying a form of PSA other than inactive free PSA and other than active free PSA, in a biological sample of the same nature.
Dependencies are inferred from the claim text.